Back to resultsBone Health Management for Women Diagnosed With Breast Cancer
Primary Purpose
Osteoporosis, Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Educational materials/mail
Educational materials/participant choice
Sponsored by
About this trial
This is an interventional prevention trial for Osteoporosis focused on measuring Osteoporosis, DXA Screening, Women, Breast Cancer, Survivors, Educational materials, Personal choices on delivery methods
Eligibility Criteria
Inclusion Criteria:
- Women
- Is 65-75 year old on July 1st, 2015
- Lives in British Columbia (BC), Canada
- Reads and understands the information provided in English
- Was diagnosed with breast cancer prior to July 1st, 2012
- Is not receiving surgery, radiation or chemotherapy for any cancers
- Has not had breast cancer spread beyond her breast(s) and nearby lymph nodes
- Has not had screening tests after July 1st, 2012
- Is not taking medications prescribed by doctors for osteoporosis
Exclusion criteria:
- Is medically unfit for preventive care (death, cognitive impairment, nursing home admission, severe mental illness, etc), which will be determined by their family doctors
- Have terminated patient-doctor relationship with her family doctor who is indicated in our record
Sites / Locations
- BC Cancer Research Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Educational materials/mail
Educational materials/participant choice
Control
Arm Description
Participants in this group will receive educational materials by mail on the first day of the follow-up period.
Participants in this group will receive educational materials by participant choice on the first day of the follow-up period.
Participants in this group will not receive any educational materials during hte follow-up period. Educational materials will be sent by mail after the completion of this study.
Outcomes
Primary Outcome Measures
DXA screening rates
Secondary Outcome Measures
Percentage of participants diagnosed with osteoporosis
Percentage of participants initiating osteoporosis medication
Changes in Calcium in take
measured as mg per week using validated questionnaires
Changes in vitamin D status
measured as scores using validated questionnaires
Changes in exercise patterns
measured as scores using validated questionnaires
Full Information
NCT ID
NCT02484131
First Posted
June 12, 2015
Last Updated
March 23, 2017
Sponsor
University of British Columbia
Collaborators
British Columbia Cancer Agency
1. Study Identification
Unique Protocol Identification Number
NCT02484131
Brief Title
Bone Health Management for Women Diagnosed With Breast Cancer
Official Title
Bone Health Management for Women Diagnosed With Breast Cancer: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
February 20, 2017 (Actual)
Study Completion Date
March 20, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
British Columbia Cancer Agency
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to test the feasibility of the study protocol. The study protocol was designed to evaluate questions - "Do educational materials improve dual x-ray absorptiometry (DXA) screening rates for women diagnosed with breast cancer" and "Does educational materials delivered by the participant's selected choice change DXA screening rates compared to the conventional mail method?".
Detailed Description
"Bone health management" for osteoporosis is important for women diagnosed with breast cancer. Osteoporosis can lead to bones breaking easily. Broken bones may make living independently challenging. Effective bone health management can reduce the risk of broken bones. This study will examine whether providing "osteoporosis information" to women diagnosed with breast cancer will promote their bone health management. With the current advance in technology, people are more interested in receiving information by email or smartphone text messaging. This study will also examine whether delivering osteoporosis information in different ways will change bone health management.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Breast Cancer
Keywords
Osteoporosis, DXA Screening, Women, Breast Cancer, Survivors, Educational materials, Personal choices on delivery methods
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
data analyst
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Educational materials/mail
Arm Type
Experimental
Arm Description
Participants in this group will receive educational materials by mail on the first day of the follow-up period.
Arm Title
Educational materials/participant choice
Arm Type
Experimental
Arm Description
Participants in this group will receive educational materials by participant choice on the first day of the follow-up period.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants in this group will not receive any educational materials during hte follow-up period. Educational materials will be sent by mail after the completion of this study.
Intervention Type
Behavioral
Intervention Name(s)
Educational materials/mail
Intervention Description
Participants in this group will receive any educational materials by mail during hte follow-up period.
Intervention Type
Behavioral
Intervention Name(s)
Educational materials/participant choice
Intervention Description
Participants in this group will not receive any educational materials by participant choice during hte follow-up period.
Primary Outcome Measure Information:
Title
DXA screening rates
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Percentage of participants diagnosed with osteoporosis
Time Frame
6 months
Title
Percentage of participants initiating osteoporosis medication
Time Frame
6 months
Title
Changes in Calcium in take
Description
measured as mg per week using validated questionnaires
Time Frame
6 months
Title
Changes in vitamin D status
Description
measured as scores using validated questionnaires
Time Frame
6 months
Title
Changes in exercise patterns
Description
measured as scores using validated questionnaires
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women
Is 65-75 year old on July 1st, 2015
Lives in British Columbia (BC), Canada
Reads and understands the information provided in English
Was diagnosed with breast cancer prior to July 1st, 2012
Is not receiving surgery, radiation or chemotherapy for any cancers
Has not had breast cancer spread beyond her breast(s) and nearby lymph nodes
Has not had screening tests after July 1st, 2012
Is not taking medications prescribed by doctors for osteoporosis
Exclusion criteria:
Is medically unfit for preventive care (death, cognitive impairment, nursing home admission, severe mental illness, etc), which will be determined by their family doctors
Have terminated patient-doctor relationship with her family doctor who is indicated in our record
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Dawes, MD, PhD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John J. Spinelli, PhD
Organizational Affiliation
British Columbia Cancer Agency
Official's Role
Principal Investigator
Facility Information:
Facility Name
BC Cancer Research Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1L3
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Bone Health Management for Women Diagnosed With Breast Cancer
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